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A Multicenter Study to Evaluate Safety and Efficacy and Usefulness of DDX-01 which Supports Screening for Diabetic Retinopathy and Diabetic Macular Edema in Internal Medicine for Japanese Patients with Diabetes Mellitus

A Study to Evaluate Efficacy of DDX-01 which Supports Screening for Diabetic Retinopathy and Diabetic Macular Edema

Tomita Koji

MEDISCIENCE PLANNING INC.

2-27-1 Shinkawa, Chuo-ku TOKYO

dxs01@mpi-cro.jp

Tomita Koji

MEDISCIENCE PLANNING INC.

2-27-1 Shinkawa, Chuo-ku TOKYO

+81-3-5544-8902

dxs01@mpi-cro.jp

Complete

Oct. 03, 2022

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

diagnostic purpose

1. Japanese ancestry who understands the study and volunteer to sign the informed consent
2. Age 18 or older
3. Documented diagnosis of diabetes mellitus, per any of the following:
a. Having met the criteria established by either the World Health Organization (WHO) or the American Diabetes Association (ADA)
b. Hemoglobin A1c (HbA1c) greater than or equal to 6.5%
c. Fasting Plasma Glucose (FPG) greater than or equal to 126 mg/dL (7.0 mmol/L)
d. Oral Glucose Tolerance Test (OGTT) with two-hour plasma glucose (2-hr PG) greater than or equal to 200 mg/dL (11.1 mmol/L), using the equivalent of an oral 75 g anhydrous glucose dose dissolved in water
e. Symptoms of hyperglycemia or hyperglycemic crisis with a random plasma glucose (RPG) greater than or equal to 200 mg/dL (11.1 mmol/L)

1. Persistent vision loss, blurred vision, or floaters.
2. Diagnosed with macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion.
3. History of laser treatment of the retina or injections into either eye, or any history of retinal surgery.
4. Subject is contraindicated for imaging by fundus imaging systems used in the study due to any of the following:
a. Subject is hypersensitive to light
b. Subject recently underwent photodynamic therapy (PDT)
c. Subject is taking medication that causes photosensitivity
5. Currently participating in another investigational eye study and actively receiving investigational product for Diabetic retinopathy or Diabetic macular edema.
6. Subject has a condition that, in the opinion of the Investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure or glycemic control, microphthalmia or previous enucleation).

Both

Diabetis

The AI diagnostic device "DDX-01" analyses retinal images of diabetic subjects taken with a non-mydriatic retinal camera and conducts screening tests for diabetic retinopathy and diabetic macular edema. The number of the hospital is one time. Subjects in the "DDX-01" arm are required to do the following:

1. Completed the PRE-DDX-01 Subject Questionnaire,
2. Underwent an imaging procedure using Topcon NW400 camera assisted by DDX-01 at the clinic,
3. Completed the POST-DDX-01 Subject Questionnaire, and
4. Continued to the Ophthalmology Clinic for examination by ophthalmologist, and had Wisconsin Reading Center [(WRC) formerly known as FPRC] imaging performed by a certified photographer.

The subject in the referral arm receives a standard referral to ophthalmology.

Sensitivity and specificity of DDX-01 in Japanese ancestry subjects

1) Overall sensitivity and specificity of DDX-01 in Japanese and US subjects
2) Absence of effect of Japanese ancestry on sensitivity and specificity as compared to non-Japanese ancestry
3) Sensitivity and specificity of Japanese ophthalmologists in Japanese subjects
4) Sensitivity and specificity of DDX-01 outputs using a clinical reference standard of diagnoses made by Japanese ophthalmologists in Japanese subjects
5) PPV, NPV, PLR, NLR in Japanese subjects
6) Difference between the proportion of Japanese subjects in the "DDX-01 arm" and those in the "standard referral arm" who receive a Diabetic retinopathy examination
7) Patient and clinician satisfaction and behavior measured by the Likert scale in Japanese subjects

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Jan. 24, 2022

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Jan. 24, 2022

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Jan. 24, 2022

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Jan. 24, 2022

No

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